January 1, 2014Thrombosis JournalOpen Access

Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Venous thromboembolism (VTE) and renal impairment (n=8246). Intervention: Rivaroxaban vs. Enoxaparin followed by a vitamin K antagonist (VKA). Primary outcome: Recurrent VTE (HR 0.89, 95% CI 0.66-1.19, p=<0.001 for noninferiority margin of 1.75).

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Key result

Rivaroxaban was noninferior to enoxaparin/VKA for preventing recurrent VTE (HR 0.89) and, unlike enoxaparin/VKA, did not increase the risk of major bleeding in patients with renal impairment.

Why the study?

Does fixed-dose oral rivaroxaban reduce recurrent VTE and bleeding compared to enoxaparin/VKA in patients with VTE and renal impairment?

Population

8,246 patients with venous thromboembolism with and without renal impairment, enrolled from 2007 to 2011…

Comparison

Fixed-dose oral rivaroxaban vs Enoxaparin/vitamin K antagonist (VKA)

Design

RCT

Authors

RBRupert BauersachsVascular Medicine ALAnthonie WA LensingBayer (Germany)MPMartin H. PrinsVascular Medicine

Discussion

Member takes

Implication

May support rivaroxaban preference in VTE with renal impairment to limit bleeding; leaves open dedicated trials for severe cases.

Study Design

Type

RCT (n=8,246)

Blinding

Open-label

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does fixed-dose oral rivaroxaban reduce recurrent VTE and bleeding compared to enoxaparin/VKA in patients with VTE and renal impairment?

Population

8,246 patients with acute, symptomatic venous thromboembolism, stratified by renal function, treated for 3, 6, or 12 months.

Intervention

Fixed-dose oral rivaroxaban

Comparator

Enoxaparin/vitamin K antagonist (VKA)

Outcome

Recurrent VTE and major or clinically relevant nonmajor bleedinghard clinical

Main Result

Hazard Ratio: 0.89 (95% CI 0.66–1.19)

Absolute Event Rate: 2.1% vs 2.3%

p-value: p=<0.001 for noninferiority margin of 1.75

In patients with VTE and renal impairment, rivaroxaban provides similar efficacy to enoxaparin/VKA but significantly reduces the risk of major bleeding.

Limitations

Exclusion of patients with a high bleeding risk or severe renal impairment (CrCl <30 ml/min)
Data collection did not account for significant changes in patients' renal function over the course of treatment
Very limited number of patients with severe renal impairment

Cite This Study

Bauersachs et al. (2014) conducted an RCT in Venous thromboembolism (VTE) and renal impairment (n=8,246). Rivaroxaban vs. Enoxaparin followed by a vitamin K antagonist (VKA) was evaluated on Recurrent VTE (HR 0.89, 95% CI 0.66-1.19, p=<0.001 for noninferiority margin of 1.75). Rivaroxaban was noninferior to enoxaparin/VKA for preventing recurrent VTE (HR 0.89) and, unlike enoxaparin/VKA, did not increase the risk of major bleeding in patients with renal impairment.

synapsesocial.com/papers/6a581fa54075ee146068d885 https://doi.org/10.1186/1477-9560-12-25

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January 1, 2014Thrombosis JournalOpen Access

Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment

View Full Paper

Ask AI

Bookmark

Key result

Rivaroxaban was noninferior to enoxaparin/VKA for preventing recurrent VTE (HR 0.89) and, unlike enoxaparin/VKA, did not increase the risk of major bleeding in patients with renal impairment.

Why the study?

Does fixed-dose oral rivaroxaban reduce recurrent VTE and bleeding compared to enoxaparin/VKA in patients with VTE and renal impairment?

Population

8,246 patients with venous thromboembolism with and without renal impairment, enrolled from 2007 to 2011…

Comparison

Fixed-dose oral rivaroxaban vs Enoxaparin/vitamin K antagonist (VKA)

Design

RCT

Authors

RBRupert BauersachsVascular Medicine ALAnthonie WA LensingBayer (Germany)MPMartin H. PrinsVascular Medicine

Discussion

Member takes

Implication

May support rivaroxaban preference in VTE with renal impairment to limit bleeding; leaves open dedicated trials for severe cases.

Study Design

Type

RCT (n=8,246)

Blinding

Open-label

Randomization

Randomized

Multicenter

Yes

Structured PICO

Does fixed-dose oral rivaroxaban reduce recurrent VTE and bleeding compared to enoxaparin/VKA in patients with VTE and renal impairment?

Population

8,246 patients with acute, symptomatic venous thromboembolism, stratified by renal function, treated for 3, 6, or 12 months.

Intervention

Fixed-dose oral rivaroxaban

Comparator

Enoxaparin/vitamin K antagonist (VKA)

Outcome

Recurrent VTE and major or clinically relevant nonmajor bleedinghard clinical

Main Result

Hazard Ratio: 0.89 (95% CI 0.66–1.19)

Absolute Event Rate: 2.1% vs 2.3%

p-value: p=<0.001 for noninferiority margin of 1.75

In patients with VTE and renal impairment, rivaroxaban provides similar efficacy to enoxaparin/VKA but significantly reduces the risk of major bleeding.

Limitations

Exclusion of patients with a high bleeding risk or severe renal impairment (CrCl <30 ml/min)
Data collection did not account for significant changes in patients' renal function over the course of treatment
Very limited number of patients with severe renal impairment

Cite This Study

synapsesocial.com/papers/6a581fa54075ee146068d885 https://doi.org/10.1186/1477-9560-12-25

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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